Association Between Post-covid Infection Status and Perioperative Morbidity: A Ambispective Cohort Study

January 10, 2024 updated by: Peking Union Medical College Hospital

With the knowledge of currently transmitted omicron variant being less virulent, over 90 percent of the Chinese population is fully vaccinated, and the Chinese health workers have sufficient experience treating the illness. China 's epidemic prevention and control has entered a new stage to restore the normal functioning of society and basic medical services, On Dec, 7, China released a circular on further optimizing its COVID-19 response, announcing 10 new prevention and control measures.This has marked the watershed for sharply increased number of elective surgical patients diagnosed with COVID-19 during preoperativley, fully recovered or during recovery.

Beijing faced a wave of omicron infection starting that would result in of a wide range of population infections. At which time there is limited evidence regarding the optimal timing of surgery following SARS-CoV-2 infection especially for omiron among Chinsese patients .This study intends to explore the relationship between the incidence of postoperative complications after elective surgery and COVID-19 infection in Peking Union Medical College Hospital, and provide data support for the policy formulation of elective surgical timing for patients after COVID-19 infection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

For the part of retrospective study，the investigators intend to include patients who had pre-operative SARS-CoV-2 infection diagnosis and received inpatient surgical intervention at Peking Union Medical College Hospital from December 1, 2022 to January 8, 2023.

For the part of prospective study，the investigators intend to include patients who will receive inpatient surgical intervention with pre-operative SARS-CoV-2 infection diagnosis at Peking Union Medical College Hospital from January 9, 2023 to February 28, 2023.

Description

Inclusion Criteria:

1. All patients having pre-operative SARS-CoV-2 infection diagnosis Dec 1st 2022 to Feb 28th 2023.

[The COVID-19 diagnosis is based on either (a) a positive RT-PCR nasopharyngeal swab, (b) positive antigen rest before surgery, or (c) clinical diagnosis made before surgery].

Exclusion Criteria:

  1. Patients diagnosed with SARS-CoV-2 infection on the day of surgery or during postoperative days.
  2. Day surgery or outpatient surgery.
  3. Patients unwilling to participate or provide COVID-19-related information.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
0-1 week group
Patients who have been infected with Covid-19 with 0-1 week post-COVID interval before surgery.
Procedure: Receiving inpatient surgical intervention
Receiving inpatient surgical intervention in Peking Union Medical College Hospital
1-2 weeks group
Patients who have been infected with Covid-19 with 1-2 weeks post-COVID interval before surgery.
Procedure: Receiving inpatient surgical intervention
Receiving inpatient surgical intervention in Peking Union Medical College Hospital
2-3 weeks group
Patients who have been infected with Covid-19 with 2-3 weeks post-COVID interval before surgery.
Procedure: Receiving inpatient surgical intervention
Receiving inpatient surgical intervention in Peking Union Medical College Hospital
3-4 weeks group
Patients who have been infected with Covid-19 with 3-4 weeks post-COVID interval before surgery.
Procedure: Receiving inpatient surgical intervention
Receiving inpatient surgical intervention in Peking Union Medical College Hospital
4-5 weeks group
Patients who have been infected with Covid-19 with 4-5 weeks post-COVID interval before surgery.
Procedure: Receiving inpatient surgical intervention
Receiving inpatient surgical intervention in Peking Union Medical College Hospital
5-6 weeks group
Patients who have been infected with Covid-19 with 5-6 weeks post-COVID interval before surgery.
Procedure: Receiving inpatient surgical intervention
Receiving inpatient surgical intervention in Peking Union Medical College Hospital
over 6 weeks group
Patients who have been infected with Covid-19 with over 6 weeks post-COVID interval before surgery.
Procedure: Receiving inpatient surgical intervention
Receiving inpatient surgical intervention in Peking Union Medical College Hospital

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Perioperative complications
Time Frame: During the procedure
The composite primary outcome included pulmonary complications (pneumonia, acute respiratory distress syndrome, or acute respiratory failure, reintubation, unplanned use or prolongation of postoperative mechanical ventilation), cardiovascular complications (deep vein thrombosis, pulmonary embolism, myocardial infarction, newly onset arrhythmia, ischemic stroke, and acute kidney injury), and infectious complications other than pulmonary infection (urinary tract infection, surgical site infection, and sepsis).
During the procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of intensive care unit stay
Time Frame: Immediately after leaving intensive care unit
Calculate the number of days the patient stays in the intensive care unit after surgery.
Immediately after leaving intensive care unit

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Readmission rate during 30 days after surgery
Time Frame: 30 days after operation
Readmission due to surgery complications during 30 days after operation
30 days after operation
Length of hospital stay
Time Frame: Immediately after discharge
Calculate the number of days the patient stays in the hospital.
Immediately after discharge
Postoperative mechanical ventilation time
Time Frame: During the procedure
Length of mechanical ventilation time after surgery
During the procedure
Intraoperative respiratory complication
Time Frame: During the surgery
Intraoperative respiratory complication: a composite of intraoperative bronchospasm, poor oxygenation, and reintubation.
During the surgery
the WHODisability Assessment Schedule (WHODAS 2.0)
Time Frame: 6 months after operation
  • Step 1-Summing of recoded item scores within each domain.
  • Step 2-Summing of all six domain scores.
  • Step 3-Converting the summary score into a metric ranging from 0 to 100 (where 0=no disability; 100=full disability).
6 months after operation
Brief Pain Inventory (BPI)
Time Frame: 6 months after operation
Brief Pain Inventory used to assess the intensity of pain
6 months after operation
Mortality after operation
Time Frame: 1 month, 3 months, 6 months, 12 months after operation
Mortality after operation in 1 month, 3 months, 6 months, 12 months
1 month, 3 months, 6 months, 12 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Shen Le, PhD, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 9, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K23C0257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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